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< Back Podcast Monday Dec 20, 2021 Dietary Supplements, DSHEA, and Marketing Claims Health Quest Podcast This was a great conversation about the safety of dietary supplements, marketing claims, how to choose supplements, and the history of DSHEA. This conversation that is worth listening to if you are interested in supplement manufacturing, marketing, or are just a consumer looking to learn about the history of our wonderful supplement industry. Listen Previous Next

Asa and other industry leaders weigh in < Back Regulators mostly silent on GLP-1 supplement claims Rachel French Interview Asa and other industry leaders weigh in The number of dietary supplement brands that make GLP-1-related claims is spiking. Yet, the emerging category of supplements has been largely met with silence from regulators, creating ambiguity for brands. Ozempic and similar drugs, classified as GLP-1 (glucagon-like peptide-1) agonists, were initially designed for the treatment of type 2 diabetes, but now are commonly used for weight loss. The drugs have seen immense popularity in recent years. One study published in the Annals of Internal Medicine identified a 700% increase in prescriptions for GLP-1 drugs in patients with overweight or obesity diagnoses over a four-year period. The study — which tapped 45 million de-identified medical records — found about 21,000 patients in the U.S. were using GLP-1 drugs to treat overweight or obesity in 2019, compared to 174,000 in 2023. Read More Previous Next

< Back In-Person, Panel Discussion Thursday Jan 23, 2025 Our Commitment to Product Integrity Organic & Natural Health Association Fort Lauderdale, FL 12:15 – 1:30 pm Our Commitment to Product Integrity Amy Summers Founder & President Pitch Publicity & INICIVOX- Moderator Deleo de Leonardis, CEO Co- Founder, Purity IQ Erin Taraborrelli, Program Manager, Labeling & Training Services, SGS nutrasource Ray Martinez, President, Florida Supplement Sandra Baek Lee , CEO, NJ Labs Asa Waldstein, Founder and Principal, Apex Compliance Learn More Previous Next

Companies that compensate influencers or affiliates may be responsible for claims they make < Back MLM Company Cited For Claims Made By Their Affiliates Companies that compensate influencers or affiliates may be responsible for claims they make This is the one-year anniversary of #WarningLetterWednesday. I have written this post every week, even when having Covid, on a tropical vacation, or under a massive work deadline. I love writing this post and hope you find as much joy in it as I do. Today’s post is unique. It involves an MLM company that was cited for claims made by company “consultants,” which is very similar to influencers or affiliates that receive compensation for referral sales to a company website. This is the first time I have seen a company cited for claims made by its affiliates, and this is a trend to watch. From warning letter: “Consumers interested in your products are then redirected by your consultants to your websites www.youngliving.com and www.naturesultra.com to purchase your products.” One of the affiliate Instagram pages mentioned in this letter only has 627 followers, a good reminder there is no such thing as being too small to attract FDA scrutiny. Most claims cited in the warning letters are from the “consultants,” with a few exceptions such as this. From warning letter: “On your website, https://naturesultra.com ....Some studies suggest [t]he most common illnesses caused by an improperly functioning ECS are depression, Alzheimer[’]s, IBS, fibromyalgia, and even migraines” The Denver office issued this warning letter, which seems to be more rigid with online claims enforcement than other divisions or the national offices. Key takeaways are companies should remove risky words from company websites and train and monitor affiliates and influencers to ensure no disease claims are present. I look forward to hearing your comments on this very fascinating warning letter! Full warning letter DATE ORIGINALLY POSTED: 7/20/22 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Here are tips on using FDA’s ingredient directory < Back Unallowable Ingredient Results in Warning Letter Here are tips on using FDA’s ingredient directory FDA cited a company for marketing sulbutiamine, an unallowable ingredient in their dietary supplement. This is different than the standard “drug-spiked” warning letter, where companies were hiding sildenafil and diclofenac in supplements. This company actually labeled their product as Sulbutiamine Plus Brain Support. I find this warning letter interesting for several reasons. First, I do not see Sulbutiamine listed in FDA’s “Information on Select Dietary Supplement Ingredients and Other Substances” link or in previous warning letters. This link can provide some helpful information to show FDA’s thinking on why certain ingredients may be allowable. Ingredients are listed by category. Here is the breakdown (from FDA). 🔹Category 2: Ingredient is the subject of a safety communication 🔹Category 3: Ingredient is not a “dietary ingredient” under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 🔹Category 4: Ingredient is excluded from the dietary supplement definition under section 201(ff)(3) of the FD&C Act 🔹Category 5: Dietary ingredient has not met the safety standard in section 402(f)(1)(A) of the FD&C Act 🔹Category 6: New dietary ingredient has not met the safety standard in section 402(f)(1)(B) of the FD&C Act 🔹Category 7: New dietary ingredient requiring a premarket safety notification under section 413(a)(2) of the FD&C Act, but for which no notification has been submitted This warning letter does not appear to mention that any commerce or testing occurred. It simply states that the company is selling a product with sulbutiamine, which is not a legal dietary ingredient or food additive. There is no statement such as “we reviewed your website over the past few months and see that you sell a product into interstate commerce.” FDA’s budget has been slashed, and we may see more of these low-lift letters in the future. I also ran the company’s website through Apex Compliance and found that the company is making disease claims on many other products but no disease claims are mentioned in this warning letter. I Googled sulbutiamine and found many well-known companies selling this ingredient. I expect more enforcement and private litigation around this ingredient in the near future. Read the warning letter . DATE ORIGINALLY POSTED: 5/21/25 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Product reviews must be honest and truthful < Back Online company fined $4.2M for blocking negative product reviews Product reviews must be honest and truthful #WarningLetterWednesday Online company fined $4.2 million for blocking negative product reviews. The FTC alleges the company blocked product reviews with less than four stars. This is considered deceptive marketing and clearly warns companies that product reviews should be accurate. Here is what we can learn. 🔷Best practices for soliciting and posting reviews. From FTC letter ➡️Examples may include asking for reviews only from those likely to leave positive ones, preventing or discouraging submission of negative reviews, subjecting negative reviews to greater scrutiny, refusing to publish negative reviews, or otherwise not treating positive and negative reviews equally. 🔷Here are some FTC rules for possible exceptions to the "post all" rule. From FTC press release➡️(the company) must post on its website all customer reviews of products currently being sold—with the exception of reviews that contain obscene, sexually explicit, racist, or unlawful content and reviews that are unrelated to the product or customer services like shipping or returns. Here is a video about product reviews . Read the FTC press release . This is a different Warning Letter Wednesday because it is an FTC action (not FDA), and it involves a fine (not a warning letter) and doesn't include a supplement company. This is a good reminder that we can learn from other agency actions such as this one. 👉Join my Warning Letter Wednesday group here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Remove COVID claims including on YouTube < Back The First 2023 Warning Letter Belongs to a CBD Company Remove COVID claims including on YouTube The first "supplement" warning letter of 2023 belongs to a CBD company. 2022 was the year of the CBD warning letter, and FDA enforcement in this area appears to be continuing. This warning letter is another reminder that no company is "too small to be off FDA's radar." A video cited in this letter only had 19 views at the time I wrote this post! This is the most unpopular video I have ever seen cited in a warning letter demonstrating that any online marketing is fair game for enforcement. I write more about this here . This company was marketing a cannabinoid product for COVID protection on its website, socials, and YouTube. There were several similar warning letters last year involving companies citing research about cannabinoids and COVID. I usually take a "maybe they didn't know any better” attitude when looking at enforcement and compliance, but in this case, the company should have known better because of the well-publicized action against other CBD companies for this same type of statements. Here are some critical posts about CBD enforcement in 2022. CBD enforcement is top of mind for FDA. This includes animal warning letters . CBD and anxiety claims . Citing clinical studies . Natural Products Insider Q4 Update . This letter mentions several claims made in YouTube videos. Last year nine warning letters cited claims made on YouTube, and I expect this enforcement trend to continue. I write more about this here . This letter cites claims made on the company's social media from early in the pandemic. As we've discussed many times on Warning Letter Wednesday several times before, companies are responsible for all social media posts, even if they are several years old. From warning letter. "COVID prevention with CBD? Canada study shows it's possible. Might be time to start a daily dose of…… all-natural pharmaceutical grade CBD products…. USE CODE: COV19" [from a May 15, 2020, post on your Facebook social media webpage" This letter also cites the product code "COV19" which is a bold claim and further shows the intended marketing use of the product. This is a reminder that items like meta tags, product tags, search tags, and coupon codes are considered marketing. This is a joint FDA and FTC warning letter, which is common when COVID claims are cited. This is serious, and it also involves a cease and desist barring the company from making COVID-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers. Read the full warning letter here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Some of our favorite resources to help educate about influencer marketing and product review compliance. Influencer Marketing & Reviews / Influencer Marketing & Product Reviews These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Product reviews and testimonials podcast: Justin Prochnow How influencers can comply with FTC disclosure guidelines video FTC's Disclosures 101 for social media influencers FTC's featuring online customer reviews: A guide for platforms Influencers and CBD: Interview with Asa and a popular influencer Back

Consulting and advisory services for the dietary supplment and hemp industries. Formulation, GMP review, FDA/FTC enforcement trend analysis, company marketing risk training. COMPLIANT MARKETING STRATEGY REVIEW HELP AVOID WARNING LETTERS Review marketing and social media campaigns with a risk level-based analysis. Develop training and best practice documents. (social media interactions, biogs, hashtags, infographics, videos). SOCIAL MEDIA Effective marketing messaging with lower risk language. Best practices for social media managers. Do's and don'ts of reposting and hashtags. BUSINESS STRATEGY INCLUDING NEW SECTOR EXPANSION Industry expert review before expanding into supplement or hemp product categories. M&A compliance due diligence review before new acquisitions. EXPERT LABEL COMPLIANCE & COMPANY TRAININGS Product label reviews Company compliance trainings to help develop in-house expertise. Founded by Asa Waldstein , a dietary supplement and hemp expert with 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes. Asa has formulated, manufactured, and marketed hundreds of products in a compliant manner and has helped oversee three FDA CFR 111 audits without any 483s. Asa decided after years as an executive for other companies the best use of his skills was to open Supplement Advisory Group to serve the greater supplement and hemp marketplace. About Supplement Advisory Group Specializing in marketing risk analysis and practical marketing solutions on the web, social media, and product labels. We focus on finding marketing risks and providing practical lower-risk solutions on the web, social media, and product labels. This includes compliant marketing strategy review and claims risk analysis. We take a preventative approach to regulatory risk in the dietary supplement and hemp industries. Learn More Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now

Some of our favorite resources to help educate about cGMP manufacturing compliance. cGMP Guidance / cGMP Guidance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. New Cosmetic Regulations Webinar: cGMP Basics for Hemp-CBD Companies. This is an excellent training tool for your supplement or hemp company! Webinar: Preparing for FDA cGMP Facility Inspections Preparing for FDA Inspections: Fireside Chat Webinar Back

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Workshops and Webinars / Workshops and Webinar Resources These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. 06-10-22-webinar June 10th GMP & Marketing Claims Demystified Workshop: Resources Steven Yeager LinkedIn Asa Waldstein LinkedIn FDA Supplements Q&A 21 CFR 111 Subparts & descriptions 21 CFR 111 Reference guide Adverse Event Reporting guidance FDA Alerts (allergens, recalls, warning letters Common allergen labeling guidance AHPA Herbs of Commerce Labeling and Allergens Guidance Webinar: CGMP Basics for Hemp-CBD Companies: This is applicable to herbal supplement manufacturers. Regulatory hints YouTube channel AHPA Prop 65 Guidance Preparing for FDA GMP Facility Inspections Webinar Asa’s Regulatory Education Series Why avoid warning letter video Video about the risks of "THC Free" or "THC Free" labeling: Made in the USA Claims Demystified video All Natural: What can you say and what is the risk video Prop 65 webinar AHPA Prop 65 Resources 06-03-22-webinar June 3rd Webinar Resources Harris Bricken Canna Law Blog cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Hemp CBD Supplement Congress videos! Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document Getting Ready for FDA Inspections Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA SOP Templates (members only) Asa’s Regulatory Education Series video channel AHPA’s Guidance Documents HerbalGram Cannabis Resources Asa’s Regulatory Consulting Company 05-04-22-webinar May 4th Webinar Resources Burdock: Food Safety & Regulatory Compliance Consultants for FDA AHPA Hemp CBD Supplement Congress videos! Why join AHPA's Cannabis Committee? Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document AHPA NDI Workshop cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA’s Cannabis Committee AHPA’s Hemp Lexicon AHPA’s NDI Database AHPA’s Botanical Congress: May 24th Asa’s Regulatory Consulting Company Burdock Associates Webinar: GRAS & NDI Certification: Ask the expert Asa’s Next Event: Distributor Pitfalls to Avoid: Hemp and Supplement Products: Back